. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1870 
22 September 2008  
 (08-4443) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:  UNITED STATES
  
If applicable, name of local government involved:     
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Food for human and animal consumption in  the United States, except for meat, 
poultry and egg products that are exclusively regu lated by the US Depart ment of Agriculture 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  Trading 
partners 
5. Title, language and number of pages of the notified document:   Label Requirement for 
Food that has been Refused Admission into the Un ited States (Proposed Rule)  (available in 
English, 46 pages) (pre-publication copy) or (avail able in English, 13 pages) (Federal Register 
version)   
6. Description of content:   The Food and Drug Administrati on (FDA) is issuing a proposed 
rule that would require owners or consignees to  label imported food that is refused entry into 
the United States. The label would read  "UNITED STATES: REFUSED ENTRY".  The 
proposal would describe the label’s characteri stics (such as its si ze) and processes for 
verifying that the label has been affixed properl y.   FDA is taking this action to prevent the 
reintroduction of refused food into the United St ates, to facilitate the examination of imported 
food, and to implement part of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002.  
7. Objective and rationale:  [ X ] food safety, [   ] animal health,  [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease,  [   ] protect territory from other 
damage from pests    
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s) in which these are available:   Federal Register 
volume 73,  pages 54106 to 54118 (18 Septem ber 2008) (available in English) 
http://www.fda.gov/OHRMS/ DOCKETS/98fr/E8-21813.pdf    G/SPS/N/USA/1870 
Page 2  
 
  10. Proposed date of adoption:  To be determined. 
11. Proposed date of entry into force:  To be determined. 
12. Final date for comments:  2 December 2008 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body: 
Submit written or electronic comments iden tified by docket number FDA-2007-N-0465, by 
any of the following methods: 
• Federal eRulemaking Portal: http://www.regulations.gov  Follow the instructions for 
submitting comments. 
• Submit written submissions in the follo wing ways:  Fax: 301-827-6870;  Mail/Hand 
delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. 
Instructions: All submissions received must include the agency name and docket number for 
this rulemaking. All comments received  will be posted without change to 
http://www.fda.gov/ohrms /dockets/default.htm
 
13. Texts available from:  [ X ] National notificati on authority, [   ] Na tional enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS National Notification Aut hority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  
us.spsenquirypoint@fas.usda.gov 
Complete text can be also be found on the Internet at 
http://www.accessdata.fda.gov/ scripts/oc/ohrms/index.cfm  and insert Docket No. 2007-N-
0465.  For access to the docket  to read background documents or comments received, go to 
http://www.fda.gov/ohrms /dockets/default.htm  and insert the Docket No. 2007-N-0465 into 
the "Search'' box and follow the prompts.